Kornimate/medical-research-clean huggingface dataset:
assessment of pain in plantar fasciitis managed by histotripsy

Conditions: Fasciitis, Plantar; Aponeurosis Contusion

Summary: plantar fasciitis or plantar fasciitis is the most commonly reported cause of pain under the heel. its prevalence varies from 3.6 to 7% in the general population. it is a painful condition of the foot that corresponds to an inflammation of the plantar fascia. at present, histotripsy in the field of orthopedics is very little used. the concept of therapeutic ultrasound intended for the treatment of plantar fasciitis by fascial section was developed in the united states but no study evaluating its effects on pain is available. there is no equivalent study on histotripsy in the pathology of chronic plantar fasciitis or fasciitis. in this study, histotripsy will be performed using a conventional serial ultrasound system with this focused energy function. the research hypothesis is that histotripsy treatment may be an alternative to pain management in patients with plantar fasciitis who have failed conventional treatments. the main objective of this study is to evaluate the evolution of the pain felt by patients with plantar fasciitis resistant to conventional medical treatment, one month after two ultrasound histotripsy sessions.


Eligibility criteria:
inclusion criteria: * patient, male or female, aged 18 years minimum * patient with plantar fasciitis evolving for at least 6 months * patients with radiology and mri of the foot less than 3 months old * visual analogue pain scale greater than 5 at inclusion * patient in whom conventional medical treatment has failed by the combination of radial shock waves, plantar orthoses, and corticosteroid infiltration that has not provided relief. * patient affiliated with or beneficiary of a social security scheme. * patient who has been informed and has given his/her free, informed and written consent. exclusion criteria: * minor patient * major retraction of the triceps surae on the maestro oblique board test: sequelae of bone trauma to the hindfoot and ankle. * inflammatory rheumatological diseases * fibromyalgia * patients in whom a specific underlying organic pathology (inflammatory, infectious, neoplastic, etc.) has been identified. * psychiatric disorders * patient participating in another research study. * protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision * pregnant, breastfeeding or parturient woman. * patient hospitalized without consent.
evaluation of the benefit of exercise testing for the diagnosis of obstruction in the coronary arteries of the heart

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine whether exercise testing can detect an obstruction in a coronary artery, and, thereby, can avoid performing a coronary imaging in some cases. patients with a suspicion of coronary artery disease perform an exercise test on an exercise bike with increasing load. ekg, blood pressure, and other parameters are monitored. patients benefit also of either a cardiac ct scan or a coronary angiography to establish whether they really have coronary obstruction.

double product dp (product of systolic blood pressure and heart rate) is directly related to the myocardial oxygen consumption (mvo2). since o2 extraction by the myocyte in maximal at rest, only an increase in coronary blood flow can increase mvo2 during exercise. therefore, if a coronary stenosis limits the maximal coronary flow, it will limit mvo2 and dp at exercise. patients with both an exercise test and a coronary artery imaging (cardiac ct or coronary angiography) within 3 months, are included. dp increase (dp max/dp at rest) is measured during a maximal, symptom-limited exercise on a cycloergometer. dp at rest is measured either before the exercise test, at the end of the recovery period or during a visit to the cardiologist in the 2 months of the test, whichever is the smallest. the predictive power to detect a significant coronary artery stenosis is assessed by computing a receiving operating characteristic (roc) curve, its area under the curve, sensitivity, specificity, and decision thresholds. number expected: 100-120 time period of data collection: 1/1/2019 to 3/1/2022

Eligibility criteria:
inclusion criteria: * starting betweew 1/1/2019 and 3/1/2022 * 18 year-old patients or older * patients with both exercise testing and either cardiac ct or coronary angiography within 3 months * patients informed and not opposing to their participation to the study exclusion criteria: * patients unable to fully understand the information related to the study

Keywords: exercise testing coronary stenosis double product
clomid in men with low testosterone with and without prior treatment

Conditions: Hypogonadism, Male

Summary: this study aims to explore whether men with low testosterone levels, due to altered brain regulation of male hormone function, who have been previously treated with testosterone, respond as well as men who have not been so treated to clomiphene citrate, an agent commonly used for female infertility that has been shown to improve male hormone secretion in some cases.

clomiphene, an oral fda-approved agent for female infertility has been shown to normalize testosterone levels in men with hypogonadotropic hypogonadism. it appears to be safe and well tolerated. this study will compare testosterone responses to clomiphene citrate in male veterans with hypothalamic hypogonadism naïve to treatment with responses of similar patients already receiving treatment with injectable or transdermal testosterone. this is an open-label, prospective, interventional trial to be conducted in an outpatient specialty care setting. we will randomize 64 hypogonadal male veterans evenly divided between naive and previous treatment and treat for 8 weeks with clomid, increasing the initial dose of 25 mg to 50 mg/day in those who fail to achieve target testosterone level (450 ng/dl) after the first 3 weeks. endpoint measurements performed in the phoenix va health care system (pvahcs) clinical laboratory will be total testosterone as well as bioavailable testosterone and sex hormone binding globulin. total testosterone level at 8 weeks of treatment will be reported as the primary endpoint. safety measures (cbc,liver functions, psa) will be assessed at 8 weeks as well. this study will help serve as a guide for design of future studies of clomiphene in hypogonadal men.

Eligibility criteria:
inclusion criteria: * patient or eligible for care at phoenix va health care system * male ages 30-70 years * testosterone level below 250 ng/dl before treatment * able to provide informed written consent exclusion criteria: * evidence of pituitary tumor \>1mm by mri or cat scan * chronic illness (renal, cardiac, liver failure) * prostate specific antigen (psa) \>4.0 ng/ml * history of prostate, breast, or testicular cancer * eye disease compromising vision (e.g. cataracts)

Keywords: testosterone hypogonadism pituitary
an efficacy and safety study of epoetin alfa (procrit) initiated at 40,000 units every week versus 80,000 units every two weeks in anemic patients with cancer receiving chemotherapy.

Conditions: Anemia

Summary: the primary objective of this study is to compare end of study hemoglobin levels between epoetin alfa at 40,000 units administered subcutaneously once every week and at 80,000 units subcutaneously every two weeks in anemic patients with cancer receiving chemotherapy. the secondary objectives of the study are to assess the hb response, time to hb response, transfusion requirements, and safety.

this is a randomized, open-label, multi-center study to compare end of study hemoglobin level between epoetin alfa (procrit) at 40,000 units administered subcutaneously once every week (qw) and at 80,000 units subcutaneously every two weeks (q2w) in approximately 280 anemic patients with cancer receiving chemotherapy. the study hypothesis is that a dosing regimen of procrit 80,000 units q2w subcutaneously (sc) is non-inferior to a dosing regimen of procrit 40,000 units qw sc with respect to the change in hemoglobin (hb) from baseline to study week 13 for patients with chemotherapy associated anemia and this respective dosing regimen is generally well-tolerated. the patients will receive subcutaneous (under the skin) injections of epoetin alfa (procrit) at one of the following dosing regimens: 1- starting dose of 40,000 units sc qw (once every week) or 2- starting dose of 80,000 units sc q2w (every two weeks)

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of non-myeloid malignancy * baseline hemoglobin value of \<= 11 g/dl unrelated to transfusion * planned chemotherapy for a minimum of 12 weeks during the study * life expectancy of \>= 6 months * ecog performance status 0-2 exclusion criteria: * diagnosis of a myeloid malignancy or known history of myelodysplasia * planned non-palliative radiation during the study * anemia due to factors other than cancer/chemotherapy * prior treatment with epoetin alfa or any other erythropoietic agent within the previous three months * history of uncontrolled cardiac arrhythmias or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder

Keywords: procrit, erythropoietin, epoetin alfa, hemoglobin level
research on traditional chinese medicine (tcm) clinical treatment of the acute episode of bronchial asthma.

Conditions: Bronchial Asthma

Summary: bronchial asthma is a common disease and frequently encountered disease of respiratory apparatus. it has very complex mechanism and multiple inducing factors. this study will focus on a new chinese therapy on bronchial asthma, analyzing the treatment mechanism of internal and external use, based on traditional chinese medicine (tcm) theory and clinical practice. the study will also investigate the efficacy of the chinese drugs and treatments on bronchial asthma, and provide an effective therapy for this disease.


Eligibility criteria:
inclusion criteria: * age between 18 to 65 years old; * patients with mild-to-moderate bronchial asthma on attacking stage; * without cardiopulmonary or other complications; * to comply with the diagnostic standard of bronchial asthma in western medicine and tcm syndrome differentiation; * informed consent form is required to be signed. exclusion criteria: * older than 65 years or younger than 18 years old; * pregnant woman or suckling period woman; * patients combine serious primary disease in liver, renal, cardiovascular and cerebrovascular, hemopoietic system diseases,or psychosis. * severe levels of disease is between severe and critical extent. combine pulmonary heart disease or respiratory failure; * irritable the physique, or allergic to the given composition of drugs in this research; * patients who are in the process of other clinical research.

Keywords: bronchial asthma cold type heat type asthenia type tcm syndrome symptoms physical signs
neural mobilization with intermittent cervical traction on grip strength, sleep quality, and quality of life in cervical radiculopathy

Conditions: Cervical Radiculopathy

Summary: cervical radiculopathy commonly called "pinched nerve," occurs when a nerve in the neck is compressed or irritated where it branches away from the spinal cord. this may cause pain that radiates into the shoulder and/or arm, as well as muscle weakness and numbness.

cervical radiculopathy (cr) is a disorder of the peripheral nervous system that affects the normal function of the cervical nerve roots (cnrs). it is frequently linked to chronic pain and daily functional limitations. the goal of the neural tissue mobilization technique is to restore the nervous system's capacity to tolerate the normal compressive, tensile, and frictional forces that are associated with day-to-day activities and to examine the neural tension in nerves and mobilize the nerves that exhibit neural tension through passive and active movements using tensioning and gliding. cervical traction reduces pressure within the vertebral disks and unloads the structures of the spine by stretching muscles and ligaments. they are clinically important techniques that are easily understood by patients.

Eligibility criteria:
inclusion criteria: 1. subjects of any gender 2. age between 35 and 55 years 3. experience of unilateral upper-extremity pain, numbness, or paranesthesia. this must include a history of neck pain associated with radicular pain below the occiput and on one side of the neck, along with a tingling sensation on the lateral aspect of the elbow joint. 4. positive results in at least three out of four tests spurling's test, distraction test, upper limb neurodynamic test 1, and ipsilateral cervical rotation of less than 60°, according to a clinical prediction rule. exclusion criteria: 1. history of previous cervical or thoracic spine surgery 2. bilateral upper-extremity symptoms 3. signs or symptoms of upper motor neuron disease 4. medical "red flags" (e.g. tumor, fracture, rheumatoid arthritis, osteoporosis, prolonged steroid use) 4. injections in cervical spine in the past 2 weeks

Keywords: cervical radiculopathy pain sleep quality quality of life grip strength intermittent cervical traction neural mobilization
outcomes of swallowing rehabilitation after stroke

Conditions: Stroke; Cerebrovascular Accident; Dysphagia

Summary: this project proposes to evaluate the relative effectiveness of four therapy protocols for pharyngeal phase swallowing impairment in the stroke population. data derived from this study should contribute significantly to our understanding of the rehabilitative process in the neurogenic dysphagic population and will provide the foundation for the establishment of efficacious, cost-efficient patient services. 1. research question to be addressed 1. the utilization of semg biofeedback monitoring in dysphagia rehabilitation facilitates more rapid and complete recovery than traditional rehabilitation using the same swallowing exercises without exteroceptive feedback. 2. swallowing rehabilitation provided in an intensive rehabilitative programme (10 hrs of treatment in the 1st week) facilitates more rapid and complete recovery than traditionally scheduled swallowing rehabilitation (twice weekly).

this multi-site, multi-national project will evaluate the relative effectiveness of four therapy protocols for pharyngeal phase swallowing impairment in the stroke population. for this study, patients with chronic dysphagia secondary to stroke will be assigned to one of four treatment protocols. these four protocols differ in respect to the intensity of treatment and the inclusion of surface electromyography (semg) biofeedback as an adjunct to treatment. all patients will complete a total of 30 hours of therapy with data collection to assess progress at intervals of every 10 sessions. treatment outcomes will be measured using a combination of physiologic and behavioral measures. data derived from this study should contribute significantly to our understanding of the rehabilitative process in the neurogenic dysphagic population and will provide the foundation for the establishment of efficacious, cost-efficient patient services.

Eligibility criteria:
inclusion criteria: * subjects will represent the diagnostic categories of single event brain stem injury, right cortical stroke and left cortical stroke. * chronic dysphagia at least 6 months post onset secondary to single neurological event, brain stem, right cortical or left cortical stroke confirmed with ct or mri * diagnosis of chronic pharyngeal phase dysphagia based on clinical and videofluoroscopic evaluation completed within 3 weeks of beginning treatment. * must be at least 12 months post onset with no substantial recovery of swallowing function. if patients have received prior swallowing treatment, they must be at least three months post the termination of direct treatment. * mini mental status exam score \>21 exclusion criteria: * history of pre-existing dysphagia or neurologic disease prior to the onset of the current disorder. * mmse score \< 21

Keywords: stroke dysphagia rehabilitation biofeedback
dose individualization of pemetrexed - improve-iii

Conditions: Non Small Cell Lung Cancer; Mesothelioma

Summary: rationale: pemetrexed is a multi-targeted folate antagonist, which is primarily indicated for the treatment of advanced non-small cell lung cancer (nsclc) and mesothelioma. dosing of cytotoxic agents like pemetrexed requires balancing the dual risk of sub-therapy and toxicity. administration of pemetrexed to patients with a creatinine clearance \<45 ml/min is currently not advised. pemetrexed is dosed based on body surface area (bsa), while renal function and dose are the sole determinants for systemic exposure. this causes 3 major issues: 1. in patients with renal dysfunction, bsa-based dosing may lead to haematological toxicity 2. patients have to discontinue treatment due to declining renal function, and are withheld effective treatment 3. even in patients with adequate renal function (gfr \>45 ml/min) treatment may be improved by individualized dosing based on renal function, resulting in less toxicity. also, bsa-based dosing may lead to ineffective therapy in patients with above average renal function. the investigators aim to address these problems. objective: the overall main objective is to develop a safe and effective individualized dosing regimen for pemetrexed. study design: improve-iii is an explorative microdosing study to assess the extrapolability of microdose-pharmacokinetics to the pharmacokinetics of a therapeutic dose. study population: improve-iii includes 10 patients of improve-i and/or improve-ii. intervention: patients will be administered a microdose with subsequent pharmacokinetic assessment. main study endpoints: the predictive performance of microdosing to predict full dose pharmacokinetics


Eligibility criteria:
inclusion criteria: 1. ≥18 years old 2. planned for treatment with pemetrexed-based chemotherapy in improve-i or -ii. 3. eastern cooperative oncology group (ecog) performance score of 0-2 4. subject is able and willing to sign the informed consent form exclusion criteria: 1. conditions that affect haemostasis in a way that blood drawing is complicated (to be assessed by physician) 2. contraindications for treatment with pemetrexed in line with the summary of product characteristics (smpc) (except for creatinine clearance \<45 ml/min in improve-i) 1. hypersensitivity to the active substance or to any of the excipients 2. pregnancy or lactation 3. concomitant yellow fever vaccine 3. the presence of clinically relevant pharmacokinetic interactions, according to the current smpc
decisional aid intervention for women considering breast reconstruction

Conditions: Breast Cancer

Summary: this is an intervention development and pilot study whose purpose is to determine the feasibility and acceptability of the breast reconstruction decisional aid (brda) and provide preliminary data on its impact on decisional outcomes. the primary aim of this study is: "is the intervention trial feasible?" the purpose is to develop a feasible web-based decisional aid (da) for a larger scale trial. thus it is important that this trial provide evidence of feasibility. the investigators will define feasibility as the rate of study acceptance and participation. the secondary aim of this study is: " is the brda acceptable and used?" the team will evaluate brda acceptability, use, difficulty with internet use, and what factors predict uptake and use. the investigators anticipate that, due to interest in the topic, the majority of women will access the website. an additional secondary aim of this study is: "what is the impact of brda on br knowledge, attitudes about br, decisional conflict, preparedness and completeness of preparation, anxiety, and discussion with oncologist?" the purpose is to calculate effect sizes for a larger randomized trial.


Eligibility criteria:
inclusion criteria: * patient is scheduled for a surgical consult with a breast surgeon * primary diagnosis of stage 0 (ductal carcinoma in situ), 1, 2, or 3a breast cancer * patient speaks and reads english * patient is considering mastectomy exclusion criteria: * patient who selects lumpectomy and not mastectomy

Keywords: breast reconstruction
cohort of premature newborns for charaterization of the digestive microbiota in ulcerative necrotizing enterocolitis in premature infants

Conditions: Necrotizing Enterocolitis; Premature Birth

Summary: compare the bacterial digestive microbiota during the stay in neonatal intensive care between a group of premature newborns developing a nec (necrotizing enterocolitis) and a group of newborns free from nec.

monitoring of a cohort of premature newborns with constitution of a collection of biological samples. follow-up of newborns from birth up to 37 weeks of amenorrhea. the medical care of children will not be affected by their participation in the research. * sampling of amniotic fluid at the time of rupture of the water bag * sampling of the blood contained in the umbilical cord after clamping and section of the cord * sampling of meconium during the first 24 hours of life in intensive care / neonatal / maternity ward * collection of a daily stool sample until the end of hospitalization and when a nec occurs * sampling of gastric residues during an episode of nec * taking a daily sample of the newborn's enteral food * sampling of 500 µl of additional blood weekly during the punctures made for the treatment * daily statement of constants * record of all complications related to prematurity (hiv, bronchodysplastic, sepsis) * blood analysis: cbc, platelets and crp (data analyzed as part of the treatment). specific analyzes for research will assess: the level of tryptase, il4 and tlr4. the samples will be stored and analyzed in the immunology laboratory of the chu clermont ferrand (pr b. evrard) * analysis of the meconium sample and each stool emitted during hospitalization, and during an episode of ecun

Eligibility criteria:
inclusion criteria: * born prematurely \< 37 weeks of amenorrhea at the maternity ward of the chu * affiliated with a social security regime * the holders of parental authority are able to give an informed consent to participate in the research exclusion criteria: * fetal pathology * newborns whose holders of parental authority are under guardianship or under the age of 18 * refusal of participation by holders of parental authority

Keywords: necrotizing enterocolitis prematurity volatolomic and microbiological signatures mast cell activation blood tryptase assay fungal digestive colonization fecal calprotectin
transcutaneous tibial nerve stimulation for idiopathic overactive bladder

Conditions: Overactive Bladder; Overactive Bladder Syndrome; Overactive Detrusor

Summary: this study was designed to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder

idiopathic overactive bladder is defined the presence of a sense of urgency with or without accompanying urinary incontinence without an organic pathology or urinary infection. its prevalence was reported to be between 7.7 to 31 % in women. in this prospective randomized controlled study, we aim to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder.

Eligibility criteria:
inclusion criteria: * overactive bladder questionnaire validation study questionnaire 8 scores higher than 11. * post voiding residue levels less than 100 ml. * women aged between 18-70 exclusion criteria: * prior history of pelvic surgery * pelvic organ prolapsus of grade 2 or more. * current urinary tract infection

Keywords: tibial nerve stimulation